3 Ingredients To Bake The Perfect Device Development Plan

By Carolyn Rose and Sean Corrigan, Insight Product Development

The definition of what constitutes “innovation” in the medical device industry has become enigmatic in recent years. While it’s still sometimes true that cracking the technology nut can be enough to result in market success, it’s typically more nuanced than that.

To drive commercial success in a crowded market, products need to address conflicting sets of user needs while simultaneously addressing market opportunities. This results in what can be a complex puzzle — but one that must be solved, if you wish to avoid pursuing technologies that don't directly address primary user needs, incorrectly balancing or prioritizing user needs that inform development, or producing a product that meets all the specs on paper, but is not compelling or differentiated in the market.

The challenge can be distilled into three key dimensions that, weighed against one another, allow you to craft a successful development plan for a compelling product feature set:

1. Prioritized user needs
2. A market opportunity assessment
3. A technology readiness evaluation

These three factors ensure that the development team approaches product definition activities in a proactive, strategic, and balanced manner that will result in a product well-positioned to withstand regulatory scrutiny and, ultimately, to achieve commercial success.

User Needs

User needs can be interpreted as providing the capabilities a device should deliver and its context of use. There are three attributes to bear in mind when deriving user needs, each of which provides an outcome that we need to achieve, using the device as the medium.

First, ensure an appropriate level of specificity; needs must relate directly to the product category with which we’re working. For example, a need like “must be easy to use” could apply to a toaster or an auto injector, and therefore isn’t very useful to the development team. We need to tell the development team what “easy to use” means for this user with this device. However, the direction shouldn’t be prescriptive as to how a particular need is addressed. Stating that “the user must be able to activate the safety function” assumes the device has an explicit safety function, but could the development team have found a way to embed it as part of another action? The process of architecting a set of capabilities that are complementary, robust, and appropriate to the user needs is the job of the development team, and cannot be effectively achieved during the process of documenting needs. Thus, achieving appropriate specificity is about giving that development team an accurate picture of what it must deliver, but not how to deliver it.

Second, user needs must be validatable. This concept can serve as a litmus test to determine if the needs are adequately specific. If the human factors and research teams cannot conceive how to confirm, with relevant users, whether a user need has been successfully satisfied, then the need has not been effectively captured.

Third, user needs should be framed in the voice of the user, and be consistent with users’ level of understanding; they should sound as though they could have been written by the users themselves. A need such as “the monitoring device must report results 6 times per hour” might sound too specific, and it very well might be. However, if the user is a registered nurse, trained to adhere to universally recognized clinical practice that requires such frequency, this documentation could prove to be appropriate.

Having framed the user needs, we now must prioritize them. We will, of course satisfy all user needs in the end. However, it must be established which needs will be allowed to drive development, and which needs are allowed to be driven by development. This process helps to determine which device features and attributes the development team will focus on first in order to de-risk the program.

Market Opportunity

User needs identification and prioritization gives us a valuable view of development planning. However, it’s also useful to consider how needs and capabilities may have been addressed by existing products in the market, and where opportunities exist to deliver a better solution. Often these considerations equate to differentiation and market success. Such opportunities can be roughly split into three categories:

1. Feature-based opportunities — These opportunities leverage design and engineering innovation to add features that enhance performance within the core workflow of the device’s primary user. For example, this might entail reducing surgical safety risks by providing surgeons more precise control over a powered surgical handpiece.
2. Function-based opportunities — These opportunities leverage design and engineering innovation to add or extend functionality within the core workflow. Using the same example, integrating blunt suction into the surgical handpiece improves procedural efficiency by reducing the number of tool exchanges required throughout surgery.
3. Operational opportunities — These opportunities affect the lifecycle outside the core workflow of a device, and can often impact the supply chain or cost of ownership. An example would be redesigning a surgical instrument to make cleaning and sterile reprocessing faster, thereby allowing a hospital to purchase fewer devices to support the same number of procedures per day.

Mapping these types of opportunities to identified user needs can quickly highlight which user needs might already be adequately met by current solutions, and which as-yet-unmet needs might enable a next-generation device to leapfrog the competition.

Technology Readiness

The last of the three factors to consider is technology readiness. As technology enables us to deliver on user needs, it’s important to identify where these enablers already exist and can be immediately leveraged, and where a solution is compelling, but may require a nonexistent or underdeveloped technology. The former (comparable, preexisting technology) likely does not present a barrier to commercialization, while the latter could require a separate development effort — months or years long — before that technology can be introduced into a development program for a specific device.

So what constitutes a “new” technology? It’s useful to define this concept liberally. A new technology may be one that exists, but never has been used in the industry, or for the application in which we plan to use it. It may not have been used for this particular purpose because the environments to which it will be subjected (disinfection and sterilization, for example) may be harsher than it can tolerate; it may not meet biocompatibility standards; or the supply chain that produces it doesn’t meet the standard for current medical devices. Also, a new technology simply may not have proven performance, or is not/cannot be manufactured on a commercial scale. If we’re talking about something that has only been shown to work in a university lab, little may be known about how it will perform in the real world, or what it will take to manufacture it in commercial-scale quantities.

The End Result

The primary benefits of looking at these three factors side-by-side are increased development velocity and the device appropriateness that proactive planning drives. A priority always is established in development but, if we aren’t systematic and proactive about how that priority is determined, it will be ad hoc and unbalanced. This oversight can delay a product’s time to market, or lead to a feature set that doesn’t properly focus on needs, or is not seen as meaningfully differentiated to decision-makers responsible for purchasing. Conversely, a well-reasoned prioritization will ensure development resources are dedicated in a manner consistent with the goals of the program, both clinically and commercially.

About The Authors

Carolyn Rose is director of research and strategy at Insight Product Development. Carolyn works with Insight's clients generating meaningful research insights and defining actionable market opportunities. She manages a team of researchers in an immersive, process-oriented approach to better understand the behaviors, expectations, and motivations of end-users, as well as the environments, attitudes, and trends that shape them. Carolyn earned BAs in both industrial design and Spanish linguistics and literature from Syracuse University, and holds a master’s in design methods from IIT’s Institute of Design.

Sean Corrigan is director of engineering at Insight Product Development, where he is responsible for Insight's technology and R&D offerings. Sean has been working in product development since 1998. He began his career designing aircraft engines at General Electric and joined Insight in 2007. Sean also developed and implemented Insight’s ISO 13485-certified quality system and leads many of Insight’s complex development programs. He holds a BS in Physics from Alma College, a BSME from the University of Michigan, and an MSME from the University of Cincinnati.